Golimumab for Ankylosing Spondylitis
A phase three, randomized, double-blind trial of 208 patients (105 golimumab, 103 placebo) finds that intravenous golimumab 2mg/kg was efficacious in reducing the signs and symptoms of ankylosing spondylitis as compared with placebo.
At 16 weeks, significantly greater proportions of golimumab patients vs placebo patients had ASAS20 (73.3% vs. 26.2%), ASAS40 (47.6% vs. 8.7%), and BASDAI 50 (41.0% vs. 14.6%) responses (all p<0.001; Table). Reductions in BASFI were also significantly greater with golimumab.
“Safety and Efficacy of Intravenous Golimumab in Adult Patients with Active Ankylosing Spondylitis: Results through Week 28," Atul A. Deodhar. 2016 ACR/ARHP Annual Meeting. Abstract number 1043. Nov. 13, 2016.
Lesinurad and Allopurinol as One for Gout
Gout patients on receiving both lesinurad and allopurinol for two years continue to meet their sUA target levels in this phase three trial.
Patients received 200 or 400 mg lesinurad combine with allopurinol, achieved target sUA <6.0 mg/dL at 6 and 12 months than with ALLO alone (P<0.0001).
The safety profile of lesinurad and allopurinol was comparable to allopurinol alone.
“Examination of Serum Uric Acid (sUA) Lowering and Safety With Extended Lesinurad + Allopurinol Treatment in Subjects With Gout (CLEAR Extension),” Kenneth G. Saag. 2016 ACR/ARHP Annual Meeting. Abstract number 208. Nov. 13, 2016.
Lesinurad Combo Therapy for Gout
At the approved dose of 200 mg once daily combined with an xanthine oxidase inhibitor, lesinurad demonstrated a consistent safety profile gout. Treatment-emergent adverse event rates comparable to those with xanthine oxidase inhibitor alone.
University of Chicago researchers pooled data to investigate the safety of lesinurad 200 and xanthine oxidase inhibitor and lesinurad 400 with xanthine oxidase inhibitor in three core studies and two extension studies for two years.
Treatment-emergent adverse events were higher for lesinurad 400 than 200 mg and placebo in combination with xanthine oxidase inhibitor. However, there were no new safety concerns in the extension studies.
“Integrated Safety of Lesinurad, A Novel Uric Acid Reabsorption Inhibitor for the Treatment of Gout,” Michael A. Becker. 2016 ACR/ARHP Annual Meeting. Abstract number 207. Nov. 13, 2016.
Treatment-Associated Renal Adverse Events
Lesinurad for gout patients at 200 mg once daily combined with a xanthine oxidase inhibitor demonstrated infrequent rates of renal-related adverse events, except for higher serum creatinine elevations. Most of the serum creatinine elevations in core and extension studies resolved.
Researchers from the University of California, San Diego investigated renal-related safety of lesinurad 200 and xanthine oxidase inhibitor and of lesinurad 400 and xanthine oxidase inhibitor in three core studies and two extension studies for 24 months.
In core studies, the most common treatment-emergent adverse events were blood creatinine increased, blood urea increased, renal failure, and renal impairment, which were consistent in core and extension studies.
“Renal Safety of Lesinurad: A Pooled Analysis of Phase III and Extension Studies,” Robert Terkeltaub. 2016 ACR/ARHP Annual Meeting. Abstract number 206. Nov. 13, 2016.
Combination Treatment for Gout
Two randomized, double-blind, phase three extension studies show that gout patients treated with lesinurad and an xanthine oxidase inhibitor for up to two years exhibited continued increases in the rate of complete resolution of tophi and reduction in tophus area, as well as decreased rates of gout flares.
Researchers from Lariboisiere Hospital evaluated the impact of long-term treatment with either lesinurad 200 and xanthine oxidase inhibitor or lesinurad 400 with xanthine oxidase inhibitor on complete resolution of target tophi and gout flare requiring treatment rates in CLEAR and CRYSTAL extension studies.
Over 24 months, the researchers saw increased rates of complete resolution of tophi, continued reductions in total tophus area and decreased proportions of subjects with gout flares requiring treatment.
“Clinical Response of Tophus and Flares to Extended Use of Lesinurad in Combination With a Xanthine Oxidase Inhibitor in Patients With Gout(CLEAR/CRYSTAL Extension),” Thomas Bardin. 2016 ACR/ARHP Annual Meeting. Abstract number 209. Nov. 13, 2016.
Click on the next page for psoriatic arthritis ACR 2016 presentation summaries.